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Study of KITE-363 or KITE-753 for Relapsed and/or Refractory B-cell Lymphoma

This study is looking at the safety and effectiveness of two investigational treatments, KITE-363 and KITE-753, for people with B-cell lymphoma that has come back or not responded to previous treatments (relapsed and/or refractory B-cell lymphoma). Both KITE-363 and KITE-753 are types of CAR-T cell therapy, which uses your own modified immune cells to fight cancer. Before receiving KITE-363 or KITE-753, you would receive chemotherapy with cyclophosphamide and fludarabine. The study aims to see how many people experience side effects and how many respond to the treatment. You may be able to join if you are 18 or older, have relapsed or refractory B-cell lymphoma with at least one measurable tumor, and have good organ function. You cannot have had CAR-T cell therapy before. The study is currently recruiting about 247 participants.

Study design
This is an interventional study with an estimated enrollment of 247 participants. It is testing two different biological treatments, KITE-363 and KITE-753.
What's involved
Eligible participants will receive lymphodepleting chemotherapy followed by a single infusion of either KITE-363 or KITE-753. Participants will then transition to a separate long-term follow-up study.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 15 years to assess objective response rate and other outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04989803

Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kite, A Gilead Company
~247 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:CyclophosphamideFludarabineKITE-363KITE-753

At a glance

Recruiting sites
27 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753
Measured over Up to 28 days
+2 more outcomes measured

Conditions

Relapsed and/or Refractory B-cell Lymphoma

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NCT04989803

Where you'd take part

This study runs at 28 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Academisch Medisch Centrum

    Amsterdam, Netherlandsno site contact published

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizonano site contact published

    Recruiting

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, Californiano site contact published

    Recruiting

  • Columbia University Irving Medical Center

    New York, New Yorkno site contact published

    Recruiting

  • Concord Repatriation General Hospital

    Sydney, New South Wales, Australiano site contact published

    Recruiting

  • Epworth Healthcare

    East Melbourne, Victoria, Australiano site contact published

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jerseyno site contact published

    Recruiting

  • Jewish General Hospital

    Montreal, Canadano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kite Study Director · STUDY_DIRECTOR · Kite, A Gilead Company

Who to contact

Medical Information
[email protected]
844-454-5483(1-844-454-KITE)
Email the study team

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Eligibility criteria

Inclusion

Relapsed and/or refractory B-cell lymphoma (R/R BCL).
At least 1 measurable lesion.
Adequate organ and bone marrow (BM) function.

Exclusion

History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years.
History of allogeneic stem cell transplant (allo-SCT).
Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion.
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.
Known history of human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) (hepatitis B surface \[HBs\] antigen \[HBsAg\] positive) infection, or hepatitis C (anti-hepatitis C virus \[HCV\] positive) infection. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing.
Individuals with suspicion and/or evidence of primary or secondary CNS lymphoma.
History or presence of a CNS disorder.
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmia, New York Heart Association Class II or greater congestive heart failure or other clinically significant cardiac disease within the 6 months before enrollment.
Primary immunodeficiency.
History of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 90 days.
Individuals with full thickness lymphoma involvement of the gastric or intestinal lining and/or transmural gastrointestinal (GI) tract involvement, or with concern for gastric or intestinal perforation or known contained gastric or intestinal perforation.
Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.

What this trial measures

  • Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753Up to 28 days

    DLTs are defined as the KITE-363-related or KITE-753-related events with onset within the first 28 days after the infusion of KITE-363 or KITE-753 respectively.

  • Phase 1b: Objective Response Rate (ORR) for KITE-363 and KITE-753 as per investigator's assessment.Up to 15 years

    ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) by the International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.

  • Phase 2: ORR as per central assessment for KITE-753Up to 15 years